A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

Trial Profile

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jun 2016

At a glance

  • Drugs PXVX 0200 (Primary)
  • Indications Cholera
  • Focus Registrational; Therapeutic Use
  • Sponsors PaxVax
  • Most Recent Events

    • 10 Jun 2016 According to a PaxVax media release, the company has received marketing approval from the United States (U.S.) Food and Drug Administration (FDA) for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Data from this and other two safety and immunogenicity trials (Profile 242534 and 242926) supported the approval.
    • 12 Mar 2016 Primary endpoint has been met. (Ninety day cholera challenge), as per an article published in the Clinical Infectious Diseases
    • 12 Mar 2016 Primary endpoint has been met. (Ten day cholera challenge), as per an article published in the Clinical Infectious Diseases
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